JOB DETAILS

JOB DETAIL

- Manage project from ideation to production handover
- Is the custodian of the Project's technical success and Project timeline through to complete production handover.
- Ensures an adequate technical team, with all interested parties represented, to progress all aspects of the project.
- Establish URS, Lead & formalize Risk analysis of the project or new equipment
- Manage the project CapEx: Investment request, PR/PO, investments follow-up & reporting, CapEx closure
- Ensures that a realistic project timeline is set up together with all colleagues
- Organizes regular meetings and/or telephone conferences to ensure that the relevant people are kept up to date and that progress is made according to the timeline.
- Lead and/or Approve design (Mechanical, Electrical, Program)
- Ensure smooth making/assembly/construction phases of the project
- Lead FAT/SAT
- Conduct Process validation (DQ/FAT/IQ/OQ/PQ) and write Validation Summary reports responsible for process performance during the production handover and the first months of

REQUIRED WORK EXPERIENCE

- Engineering background. This can be Mechanical, Industrial, or another relevant field of Engineering.
- At least 5 years of experience in technical project management with a focus on implementation/delivering projects/new processes in/for global medical device/pharmaceutical companies
- Knowledge and Experience in Packaging technology are preferred, although the position implies facing and learning new technologies.
- Knowledge of the standards for the Medical Device industry.
- Familiar with the validation flow of new processes (DQ/IQ/OQ/PQ)
- Proficiency in MS Project, Pack Office.
- Experience with CAD Software would be a plus.